Method for Wound Infection Prevention

ABSTRACT

A wound healing device and method that greatly reduces the risk of infection of an incision or wound by removing fluid from the subcutaneous skin layers. The wound healing device includes a first portion that is positioned external of, and on top of, the wound. At least one strip, cord, finger, member is in fluid communication at one end with the first portion while the second free end of the at least one strip, cord, finger, member is pushed down into the wound, in between the sutures or staples of a closed incision. Both the first portion and the at least one strip comprise fluid absorbable material for absorbing the wound fluid. The device remains in place for approximately 1-3 days after which it is removed. Upon removal, natural temporary “type of fistulae” are formed in the subcutaneous skin layers to continue draining wound fluids upward for another 1-2 days.

CROSS-REFERENCE TO RELATED APPLICATIONS

This nonprovisional application is co-pending with and continuation ofU.S. patent application Ser. No. 16/148,876 filed on Oct. 1, 2018entitled APPARATUS FOR WOUND INFECTION PREVENTION. U.S. patentapplication Ser. No. 16/148,876 was co-pending with and continuation ofU.S. patent application Ser. No. 14/193,584 filed on Feb. 28, 2014entitled APPARATUS & METHOD FOR WOUND INFECTION PREVENTION. U.S. patentapplication Ser. No. 14/193,584 was co-pending with and claims benefitof both U.S. Prov. Pat. App. No. 61/774,272 filed on Mar. 7, 2013entitled METHOD OF WOUND INFECTION PREVENTION AND CLEAN KIT and U.S.Prov. Pat. App. No. 61/914,720 filed on Dec. 11, 2013 entitled APPARATUSAND METHOD FOR WOUND INFECTION PREVENTION. This nonprovisional patentapplication claims priority to U.S. patent application Ser. No.16/148,876, U.S. patent application Ser. No. 14/193,584, U.S. Prov. Pat.App. No. 61/774,272, and U.S. Prov. Pat. App. No. 61/914,720. All theentire disclosures of the patent applications are incorporated byreference herein.

BACKGROUND

The present invention relates generally to apparatus and methods fortreating wounds, and more particularly, to an apparatus and method forhealing closed incisions following surgery.

America wastes over a billion dollars annually, on post-operativesurgical site infection expenses. These surgeries have an acknowledgedoverall infection rate of between 15%-30%. Surgical site infection slowsthe recovery rate for patients and adds additional health costs withprolonged hospital treatment, additional home care, physician office andemergency room visits expenses.

Typically, physicians often respond to the risk of wound infection withthe “open wound” technique, subjecting patients to psychological tormentof the patient knowing they have an open wound, restricting them fromnormal activity. The patient is left with a hole in their body open tothe outside; which requires additional health maintenance includingadditional dressing changes by visiting nurses, additional physicianconsultation and additional high cost of vacuum device usually for aweek or longer.

Physicians, attempts to avoid an open wound, will often install adrainage device in the patient. This is accomplished by placing aplastic tube into the patient, horizontally along the fascia layer andclosing the wound around the tube. The most common drains; the“J-Drain”, and “Penrose Drain”, do not remove fluid from all threelayers of skin, have a tendency to clog up and can even increase theproduction of additional fluid in patients; at times making theinfection and recovery issues worse. The drains must then eventually beremoved by surgeon, sometimes weeks after surgery. Research shows thesedrains have a poor rate of success with some studies showing an actualincrease in patient complications.

Patients enduring the traditional old fashioned healing systemsfrequently require weeks to recover, extensive follow-up treatments andprocedures and have increased the risk of complications and even death.

Recently, open wound “negative pressure” treatments are now also beingtouted as the answer for closed incision as well as open wound infectionpreventative treatments; this treatment simply removes excess fluid fromcutaneous areas from the outer skin level. Negative pressure treatmentsfail to effectively address the underlining cause of surgical siteinfection (SSI) in closed incisions. The negative pressure VAC (vacuum)systems are also very expensive and are physician and nurse-laborintensive. The data surrounding the VAC systems appears to be mixed andstudies appear to show that these systems involve patients with fewerhigh risk factors prior to surgery.

SSI infections may occur from the following, but not limited to:colorectal, general surgery, OBGYN, urology, vascular, neurosurgery andother procedures. The incisions or wounds closed following theirrespective surgeries are susceptible to high infection rates and slowpatient recovery periods which also impact the physician, staff,hospital, insurer, etc. Moreover, SSI costs hospitals billions ofdollars every year in the U.S. and insurance companies do not reimbursehospitals for maladies caused by infection, and correspondingcomplications, due to surgical site infection.

Thus, there remains a need for an apparatus and associated method thatenables the physician to close the wound without significantlyincreasing the risk of surgical site infection to the patient, therebybeing able to safely close more patients following surgery and improvingtheir lives. The apparatus and associated method is easy to remove fromthe patient and is a cost effective solution.

All references cited herein are incorporated herein by reference intheir entireties.

BRIEF SUMMARY

A wound healing device for applying within an incision or wound isdisclosed. The wound healing device comprises: a first portion (e.g., adressing, bandage, etc.) that is applied over the incision or wound(e.g., open or closed), wherein the first portion comprises a fluidabsorbent material (e.g., any natural or synthetic material, such butnot limited to: cotton, Teflon, nylon, packing material, etc.); a secondportion (e.g., strip, loop, tab, cord, appendage, tentacle, finger,etc.) that is in fluid communication and comprises a fluid absorbentmaterial or materials material (e.g., any natural or synthetic material,such but not limited to: cotton, Teflon, nylon, packing material, etc.)with the first portion at a first end of the second portion and a secondend of the second portion that is positioned within the wound in thesubcutaneous skin layer, wherein the second portion comprises a fluidabsorbent material (e.g., any natural or synthetic material, such butnot limited to cotton, nylon, packing material, etc.).

A method for wound healing that greatly reduces the chances forinfection of an incision or wound (e.g., open or closed) of a patient isdisclosed. The method comprises: inserting one end of at least one fluidabsorbing material (e.g., any natural or synthetic material, such butnot limited to cotton, Teflon, nylon, packing material, etc.) inside theincision or wound; positioning a second end of said at least one fluidabsorbing material (e.g., strip, loop, tab, cord, appendage, tentacle,finger, etc.) which in itself permits the inclusion of air into theincision, to be in fluid communication with another fluid absorbentmaterial (e.g., a dressing, bandage, etc. and also comprising anynatural or synthetic material, such but not limited to cotton, Teflon,nylon, packing material, etc.) that is positioned external of thepatient and over top of the incision or wound; and maintaining said atleast one fluid absorbing material and said another fluid absorbentmaterial within and top of the incision or wound respectively, forapproximately 1-3 days for conveying fluid out of the incision or woundand into the another fluid absorbent material. Because of thecommunication between the (e.g., strip, loop, tab, cord, appendage,tentacle, finger, etc.) and the outer dressing, the (e.g., strip, loop,tab, cord, appendage, tentacle, finger, etc.) cannot be accidentallyleft inside the patient.

A wound healing device for applying within an incision or wound (e.g.,open or closed) is disclosed. The wound healing device comprises: atleast one fluid absorbent material (e.g., any natural or syntheticmaterial, such but not limited to: cotton, Teflon, nylon, packingmaterial, etc.) formed into a strand (e.g., strip, loop, tab, cord,appendage, tentacle, finger, etc.) having a first end that is positionedwithin the wound or incision in the subcutaneous skin layer and whereinthe strand further comprises a second free end that protrudes out of thewound or incision.

A method for wound healing that greatly reduces the chances forinfection of an incision or wound (e.g., open or closed) of a patient isdisclosed. The method comprises: forming at least one strand of a fluidabsorbing material (e.g., any natural or synthetic material, such butnot limited to cotton, Teflon, nylon, packing material, etc.); insertinga first end of said at least one strand (e.g., strip, loop, tab, cord,appendage, tentacle, finger, etc.) inside the incision or wound;positioning a second free end of said at least one strand to bepositioned external of the patient; and maintaining said first end ofsaid at least one strand within the incision or wound for approximately1-3 days for conveying fluid out of the incision or wound and into saidstrand.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Many aspects of the present disclosure can be better understood withreference to the following drawings. The components in the drawings arenot necessarily to scale, emphasis instead being placed upon clearlyillustrating the principles of the present disclosure. Moreover, in thedrawings, like reference numerals designate corresponding partsthroughout the several views.

FIG. 1A is bottom view of the wound healing device of the presentinvention;

FIG. 1B is a side view of the wound healing device of the presentinvention;

FIG. 1C is top view of the wound healing device;

FIG. 2A is a functional diagram of the wound healing device in place inthe closed incision or wound (e.g., in a patient's abdominal wall);

FIG. 2B is a functional diagram of the closed incision following theremoval of the wound healing device, showing the formation of type offistulae in the subcutaneous tissue;

FIG. 3A is a second more simplified embodiment of the wound healingdevice;

FIG. 3B is bottom view of the second embodiment;

FIG. 3C is a top view of the second embodiment;

FIGS. 4A-4M depict a surgeon or other healthcare technician applying thewound healing device of the present invention;

FIG. 5 depicts a third embodiment of the present invention which uses acontinuous loop for the absorbent member that is disposed in the wound;

FIG. 6 depicts a fourth embodiment that uses a packing strip for thedressing and to which the absorbent members are coupled;

FIG. 7 depicts a fifth embodiment that uses a packing strip for thedressing and to which a continuous loop absorbent member is coupled;

FIG. 8 depicts a sixth embodiment of the present invention that usesextendable absorbent members fed from respective dispensers on or fromwithin the dressing;

FIG. 9 depicts a seventh embodiment of the present invention that alsouses extendable absorbent members that have extensions in the form ofloops that pass through the present invention;

FIG. 9A depicts a variation of the seventh embodiment of the presentinvention that also uses extendable absorbent members that haveextensions in the form of loops that are positioned within the bandageportion of the present invention;

FIG. 10 depicts an eighth embodiment of the present invention that alsouses extendable absorbent members wherein the extensions are formed fromexcess material formed into loops on the absorbent members;

FIG. 11 depicts a ninth embodiment of the present invention wherein theabsorbent member comprises foldable component that can be expanded intothe wound once the absorbent member is passed into the closed incision;

FIG. 12 depicts a tenth embodiment of the present invention wherein theabsorbent members are not in direct contact with the dressing butwherein fluids absorbed into the absorbent members can jump or leap intothe dressing;

FIG. 13 depicts an eleventh embodiment of the present invention whereinthe absorbent members are positioned within the wound without anycoupling to a dressing and to which at a later stage a dressing may ormay not be placed into contact with the portion of the absorbent membersthat extends out of the wound;

FIG. 14 is a functional diagram of the wound healing device in place inan open incision or wound (e.g., in a patient's abdominal wall);

FIG. 15 is a plan view of the dressing of another variation of the woundhealing device that includes a cutaway along its edge to accommodate anobstruction, such as a stoma, closely adjacent the incision or wound;and

FIG. 15A is a plan view of a further embodiment of the wound healingdevice that includes an opening in the dressing that permits anobstruction to pass through the dressing to permit the dressing to makesufficient contact with the skin when the incision or wound is closelyadjacent the obstruction.

DETAILED DESCRIPTION

Referring now to the figures, wherein like reference numerals representlike parts throughout the several views, exemplary embodiments of thepresent disclosure will be described in detail. Throughout thisdescription, various components may be identified having specificvalues, these values are provided as exemplary embodiments and shouldnot be limiting of various concepts of the present invention as manycomparable sizes and/or values may be implemented.

The wound healing device (WHD) 20 of the present application absorbsfluid from all three layers of skin, removes fluid where infection ismost common—along the incision. The WHD 20 does not clog, does notinvolve making additional holes in patient and exhibits the highestsuccess rate of any infection reduction system on the highest infectionrisk patients —patients with multiple additional high risk factorsincluding but not limited to: contaminated incision, diabetes, andmalnutrition. As will be discussed in detail, the WHD 20 is a completefluid absorption system.

As will also be discussed below, the WHD 20 is completely removed fromthe patient without re-stitching or stapling usually two days followingsurgery. In many patients once the WHD 20 is removed, no other dressingsare necessary. In most cases where an additional light dressing isrequired, it is usually removed within another day or two.

One of the key features of the WHD 20, as will also be discussed below,is that it is the only device that absorbs fluid and infectiousmaterials at the source during and after the source has formed and theWHD 20 moves the fluid and materials out of the body. Recent data usingthe WHD 20 cites the infection rate using at 4.2% and in cases whereinfection did occur, the infection was less severe and covered a smallerarea. This data is virtually identical to the probe techniques studieswhere the patient's wound is cleaned daily with a deep insertion ofcotton swabs, for five days following surgery. The probe methodologydata is very similar to that related to the WHD 20; with infection ratesof 3% and 4% and patients' hospital stays being reduced from 7 to 5days, per patient. However, even though the probe technique is highlyeffective, it still requires daily cleaning of wound by physician forfive days, and involves significant patient discomfort. It is a laborintensive solution. In contrast, the WHD 20 offers virtually identicalresults, using very similar concept but without the need of extensivephysician labor, potentially high patient discomfort and mental anguishand still only removes the fluid and potentially infectious materialafter it has collected subcutaneously.

The preferred embodiment of the WHD 20 (see FIGS. 1A-1C) comprises afirst portion 22 that is positioned on top of the patient's skin overthe wound. This first portion 22 may referred to as a “dressing”. Thedressing 22 may comprise any material, either natural or synthetic, or acombination, that can absorb fluids; for example, but not limited to,cotton, Teflon, nylon, packing material, etc. Although FIG. 1A depictsthe dressing 22 as comprising a rounded rectangular shape, the dressing22 is not limited to that shape and may assume any shape or size but aslong as it comprises a fluid-absorbing characteristic. The dressing 22may comprise a single layer or multi-layered construction, and may alsobe in combination with the use of non-adhering and/or medicated bandagematerials and/or materials that control the direction of wicking ofliquids.

In fluid communication with the first portion 22 is a second portion 24that may comprise at least strip 24 that also comprises afluid-absorbing characteristic. This second portion or strip 24 maycomprise a single element of fluid-absorbing characteristic or it maycomprise a looped construction, such as that shown by 24A in FIG. 1A. Itshould be understood that the physical construction of the strip 24 canvary and can be referred to using any number of terms, such as but notlimited to, strip, loop, tab, cord, appendage, tentacle, finger, etc.but as long as the strip 24 comprises a fluid-absorbing characteristic.The composition of the strip 24 may comprise any natural or syntheticmaterial such as, but not limited to, cotton, nylon, etc. By way ofexample only, six strips 24 are shown in fluid communication with thefirst portion 22. It is also within the broadest scope of the inventionto include materials that control the direction of wicking of liquids.This may also be in combination with the use of non-adhering and/ormedicated bandage materials. Moreover, it also within the broadest scopeof the invention wherein each of the second portion or strips 24 maycomprise a tong-like, or comb-like, form to guide or assist in placingor positioning them within in an open or closed wound or incision.

The fluid communication of the second portion 24 to the first portion 22can be achieved in several ways, one of which is by stitching or via anyother method of physically-connecting the first 22 and a first end 25Aof the second portion 24, as shown by way of example only in FIG. 1A.However, it is within the broadest scope of the present invention 20 toinclude the conveyance of fluid from the second portion 24 into thefirst 22 by way of the fluid “wicking” across a slight gap between anend of the second portion 24 and the first portion 22. This is shownmost clearly in FIG. 12 where fluid 12 absorbed into the second portion24 “leaps” or “jumps” from the extreme end of the second portion 24through a spacer 31, that physically separates the second portion 24from the first portion 22, and is finally absorbed into the firstportion 22. Thus, the use absorbent members 24 that are not directly incontact with the bandage 22 are within the broadest scope of theinvention 20.

The length of the second portion 24 is approximately 2-3 inches,although the length could vary to 4 inches or even 8 inches, dependingupon the size of the patient.

FIGS. 3A-3C shown a second, more simplified version of the WHD 20Awherein the first portion 22 comprises a swath of gauze that can befolded into a multi-layer construction and then closed 33 (e.g.,stitched) to avoid the first portion 22 from unraveling. Other thanthat, the WHD 20A operates in the same manner as the WHD 20.

FIG. 2A depicts a functional diagram of how the WHD 20/20A works wheninstalled in the wound of the patient. In particular, the surgeon orother healthcare attendant pushes each strip 24 through a portion of theclosed incision, in between the wound staples or sutures. By way ofexample only, the WHD 20/20A shown in FIG. 2A shows the invention withsix strips 24 positioned deep inside the closed incision 15 andpositioned in the subcutaneous layer tissue 16 above the muscle 18. Thefirst portion (dressing) 22 is positioned on the outer skin 14 directlyover the closed incision 15. Fluids that form in this layer are absorbedby the strips 24 and are drawn upward, as shown by arrows 32, out of theskin layers 14/16 and into the first portion (dressing) 22. By removingfluid from these skin layers immediately, the chances for infection aregreatly reduced.

Moreover, upon removal of the WHD 20/20A from the wound in approximately1-3 days, removal of the strips 24 leaves behind respective “type offistulae” 34 (see FIG. 2B) within the subcutaneous skin 16 and skin 14layers. These type of fistulae provide temporary “channels” that permitfluid in the subcutaneous layer 16 to continue to escape upward for afinite time, after removal of the WHD 20/20A, further draining thislayer 16 of fluid, and allowing air to enter the wound. In particular,once the WHD 20/20A is removed from the wound 15, a conventional bandage(not shown) is placed over the wound 15. These types of fistulae 34continue to drain fluid upward towards the conventional bandage, therebyremoving even more fluid from the subcutaneous layer 16. Eventually,these type of fistulae 34 naturally close, from the bottom upward, aftera few additional days (e.g., 1-2 days) following the removal of theapparatus but they facilitate in draining the subcutaneous layer 16 evenmore. Thus, the WHD 20/20A also provides temporary draining channels forsuch fluid that are not formed in the subcutaneous layer 16 by otherconventional draining equipment. These types of fistulae 34 serve as anatural drainage system that work in conjunction with the patient'snormal healing process and the subsequent closure of the fistula.

FIGS. 4A-4M depict an exemplary WHD 20/20A application process. Althoughthese figures show the use of only two loops 24A, it should beunderstood that this is simply by way of example and that just one, ormore than two strips/loops could be used.

After the surgery, in the domain of sutures or staples 17 of the skin 14of the subcutaneous, of the subcutaneous 16, and of the fascia, thewound and subject area 15, may be contaminated or clean contaminated orinfected wound in which liquid may accumulate and/or colonizebacteriologically, collecting from any and or all layers.

As mentioned earlier, the absorbent dressing 22 is located on thesurface of the wound 15 and subject area. Transfer of liquid and wastematerial from the wound and subject area to the dressing 22 is realizedby capillary transfer and any other method of transfer of the absorbentstrip, loop, cord or tube or appendage 24 connected or adjacent to thedressing 22 to facilitate the transfer of liquid and material from thewound area dressing 22 is provided with one or more strip, loop, cord ortube or appendage 24 which is, or is located in the area of the wound15, infected or potentially infected area and therefore facilitates theflow of liquid and bodily waste materials from the subcutaneous 16 tothe dressing absorbent material 22 outside the patient body.

The facilitation of the liquid and bodily materials especially from theincision wound 15, infected or potentially infected area or injury area,from potentially any and all subcutaneous areas and levels 16, intoabsorbent or liquid extractable strips, loops, cords, tubes or absorbentappendage 24 towards and into the adjacent or attached absorbentmaterials external to the body.

In particular, FIG. 4A shows a wound 15 in the skin 14 closed withstaples 17, where gaps 19 between the staples 17 allow the passage ofthe strips 24, as discussed below; the extreme end (i.e., second end25B) of one strip 24 can be seen at the top of FIG. 4A, being moved overa surgical covering 11.

FIG. 4B depicts the WHD 20/20A being positioned over the wound 15 (notvisible in FIG. 4B); it should be noted that the WHD 20/20A includes anadhesive border (not shown) which is covered by a release border 36along the edge of the first portion 22.

FIG. 4C shows the surgeon or other healthcare attendant manipulating theWHD 20/20A such that one of the strips 24 is positioned over a gap 19between staples 17. FIG. 4D shows the surgeon or healthcare attendant(hereinafter “surgeon”) further manipulating the WHD 20/20A in order toproperly position one of the strips 24 over a gap 19 in the wound 15between staples 17. FIG. 4E shows the surgeon seizing one of the strips24 with a clamp 2 in preparation to push the strip 24 into the gap 19;in FIG. 4F, the surgeon is pushing the free end of the strip 24 into agap 19 in the wound 15.

FIGS. 4G-4H shows the surgeon inserting another strip 24 into anothergap 19 in the wound 15. Typically, the surgeon pushes the free end ofthe strip 24 down into the gap 19 and obtains a tactile indication tostop when the surgeon feels contact with the fascia layer is made.

FIG. 4I shows both strips 24 pushed down into respective gaps 19 in thewound 15 between staples 17.

At this point, the surgeon needs only to secure the first portion(dressing) 22 down onto the skin 14 of the patient using the adhesiveborder. FIGS. 4J-4K show the surgeon applying the first portion 22 ontothe skin 14 and then removes the release liner 36 from the first portion22. FIG. 4M depicts the WHD 20/20A releasably secured in place in andover the wound 15. By way of example only, a transparent adhesive 37overlays the top surface of the dressing 22 (and to which the releaseliner 36 was originally attached) that releasably secures the dressing22 to the skin 14.

FIG. 5 depicts a third embodiment of the WHD 20B wherein the at leastone strip 24 is replaced by a continuous absorbent member 24B that isformed into a large loop. The loop 24B comprises ends that correspond toends of the first portion 22.

FIG. 6 depicts a fourth embodiment of the WHD 20C wherein the firstportion 22 is formed of a thin packing material 22A.

FIG. 7 depicts a fifth embodiment of the WHD 20D which is a combinationof the third and fourth embodiments. In particular, the first portion22A is formed of a thin packing material 22A and the at least one strip24 comprises the large loop 24B. As with the third embodiment 20B, theWHD 20D comprises the loop 24 having ends that correspond to the ends ofthe first portion 22.

Another key improvement to the WHD 20/20A is the ability to extend thelength of the at least one strip 24A. This can be advantageous for anumber of reasons. Allowing the surgeon to adjust the length of the atleast one strip 24 permits the surgeon to customize the absorbingcapability of the present invention 20 based on the patient'sphysiology. If, by way of example, the patient has a large girth, it maybe necessary to extend the length of the at least one strip 24, deeperinto the subcutaneous layer 16.

To that end, FIG. 8 depicts a sixth embodiment 20E wherein respectivecartridges 38 of strip material permit the strips 24 to be extended tonew lengths 24′, shown in phantom. Alternatively, FIG. 9 shows the useof “slack loops” 40 in a seventh embodiment 20F that project from theupper side of the first portion 22. Thus, when it becomes necessary toextend the lengths of the strips 24, the surgeon can push downward oneach strip 24 to extend the length of each strip to that shown by 24″ bya corresponding decrease 40′ in the slack loops 40. It should beunderstood that the term “slack loops” in their broadest sense mayinclude rolled, or folded or tucked fluid absorbent material strips thatare located inside or outside the first portion 22; FIG. 9A shows anexemplary embodiment 20F1 where the “slack loops” are provided withinthe first portion 22 itself. The arrow indicates movement as the strip24 is lengthened and the slack loops 40 are shortened.

FIG. 10 depicts an eighth embodiment 20G that uses “slip knots” 42 ineach strip 24 that allow each strip 24 to be lengthened by applying adownward force on each strip 24; excess material formed in the slip know42 permits the respective strip 24 to be lengthened 42′.

FIG. 11 depicts a ninth embodiment 20H wherein the second portion 24Ccomprises a foldable portion 44 that can be expanded outward within thesubcutaneous layer 16 once the second portion 24C is passed through agap 19 in the wound 15. In particular, once the second portion 24 ispushed downward in the gap 19, the surgeon can then expand the foldableportion 44 along the length of the wound 15 within the subcutaneouslayer 16.

A further variation 20J of the present invention 20 is the use of freeabsorbent members 24 being placed into the wound in between the staplesor sutures 17, wherein the upper ends 24C of the absorbent members arefree, as shown most clearly in FIG. 13 . In particular, the surgeon orother healthcare technician can insert each of these free absorbentmembers 24 in between the sutures or staples 17 in the subcutaneouslayer tissue 16 above the muscle 18, as described previously. As alsomentioned previously, these free absorbent members 24 may remain in thewound for approximately 1-3 days at which time they are then removed bythe surgeon or other healthcare technician. As also mentioned earlier,fluids that form in the wound are absorbed by the strips 24 and aredrawn upward, out of the skin layers 14/16. By removing fluid from theseskin layers immediately, the chances for infection are greatly reduced.Furthermore, the fistulae 34 are also formed as described earlier withregard to FIG. 2 . A separate dressing 22 may also be applied to theupper ends 24C during the time the free absorbent members 24 insertedinto the wound, although this is not required.

It should be understood that it is within the broadest scope of thepresent invention to include the use of all of the embodiments of theWHD in open wounds also. By way of example only, as shown FIG. 14 , theWHD 20 is placed inside an open wound, i.e., where no sutures or staplesare used to close the wound. Thus, the surgeon places the strips 24 downinto the open wound with the dressing 22 being placed at the skin level.Also by way of example only, the variation 20J discussed previously canbe placed also into the open wound and then a separate dressing 22 maybe placed in contact with the upper ends 24C of the free absorbentmembers 24.

FIGS. 15 and 15A provide further embodiments of the WHD to accommodatesurrounding items or obstructions at the skin surface that would preventthe dressing 22 from making good contact with the skin surface. Inparticular, FIG. 15 depicts a top view of this additional WHD embodiment20K whose first portion 22 comprises a dressing edge removed, forming acutaway 46. For example, a where a patient has a stoma having a tube orother lumen that is coupled thereto and the wound or incision is closelyadjacent that stoma, the WHD embodiment 20K can be positioned asdescribed previously and the dressing 20 can be positioned such that thecutaway 46 is positioned closely adjacent the stoma/tube, therebyallowing the edges of the dressing 22 of the WHD 20K to make goodcontact with the skin surface and not be interfered with by thestoma/tube. It should be further understood that the shape of thecutaway 46 is by way of example only and it is not limited to asemi-circular contour but may comprise any shape and size. In addition,the relative position of the cutaway 46 can be located along any edge ofthe dressing 22.

FIG. 15A shows another embodiment 20L of the WHD wherein an interiorportion forming an opening 48 of the dressing 22 is removed. Thus, wherethe incision or wound is located at a position closely adjacent someobstruction (e.g., a stoma, a tube, a medical device or sensor, etc.)that would prevent the dressing 22 from making sufficient contact withthe skin surface, the obstruction (not shown) can be passed through theopening 48 to permit the dressing 22 to be positioned flush against theskin surface. Again, the opening 48 is shown by way of example only;other shapes and other locations on the dressing 22 may comprise theopening 48.

It should be noted that although not required, an anti-microbialcomposition may be applied to either the first portion 22 and/or thesecond portion 24.

Thus, the present invention relates to an apparatus/method of woundinfection prevention and healing acceleration and life. The WHD 20provides the effective post-surgical clean contaminated, contaminated,clean and infected incision when the rate of infection potential isconsidered significant. The apparatus/method may also be used in avariety of medical surgeries interventions and procedures. The presentinvention 20 can also be used in veterinary medicine.

The apparatus & method for wound infection device (WHD) 20 is useful forpreventing SSI infection for the following surgeries including but isnot limited to: general surgery procedures, colorectal, OBGYNprocedures, urology, vascular surgeries, and neurosurgery procedures.The incisions or wounds closed following their respective surgeries aresusceptible to high infection rates and slow patient recovery periodswhich also impact the physician, staff, hospital, insurer, etc.Moreover, SSI costs hospitals billions of dollars every year in the U.S.and insurance companies do not reimburse hospitals for maladies causedby infection, and corresponding complications, due to surgical siteinfection.

It should be further understood that the term WHD includes any all ofkinds of kits that comprise the WHD and any associated components (e.g.,a plurality of WHDs; tools that may be used by the surgeon to insert thesecond portion 24 into wound site (e.g., pliers, tweezers, dissectors,etc.) that are provided with the WHD 20 itself.

Thus, the apparatus and method for wound infection device (WHD) 20accelerates the healing process by reducing the healing time by anaverage of 2 days per patient, which among other things, reduceshospital stay periods.

While the invention has been described in detail and with reference tospecific examples thereof, it will be apparent to one skilled in the artthat various changes and modifications can be made therein withoutdeparting from the spirit and scope thereof.

1. A method for wound healing that greatly reduces the chances forinfection of an incision or wound of a patient, said method comprising:inserting one end of at least one fluid absorbing material inside theincision or wound; positioning a second end of said at least one fluidabsorbing material to be in fluid communication with another fluidabsorbent material that is positioned external of the patient and overtop of the incision or wound; and maintaining said at least one fluidabsorbing material and said another fluid absorbent material within andtop of the incision or wound respectively, for approximately 1-3 daysfor conveying fluid out of the incision or wound and into said anotherfluid absorbent material.
 2. The method of claim 1 wherein said secondportion comprises at least one strip that is physically coupled to saidfirst portion at said second end.
 3. The method of claim 2 wherein saidat least one strip comprises a loop.
 4. The method of claim 2 whereinthe incision or wound is a closed wound or incision via sutures orstaples and wherein said at least one strip comprises a plurality ofstrips, and wherein said step of inserting one end of at least one fluidabsorbing material inside a wound comprises each of said strips beinginserted inside the wound via respective gaps between sutures or staplesof the wound.
 5. The method of claim 4 further comprising the step ofextending each one of said plurality of strips.
 6. The method of claim 1wherein said step of positioning said another fluid absorbent materialexternal of the patient includes using an adhesive to releasably securesaid another fluid absorbent material over the wound.
 7. The method ofclaim 1 further comprising the steps of: removing said one end of atleast one fluid absorbing material inside a wound and removing saidanother fluid absorbent material from over the wound; and forming typeof fistulae in subcutaneous tissue of the wound and up to the exteriorskin level, said type of fistulae causing fluid to continue to drainupward from the wound.
 8. A method for wound healing that greatlyreduces the chances for infection of an incision or wound of a patient,said method comprising: forming at least one strand of a fluid absorbingmaterial; inserting a first end of said at least one strand inside thewound or incision; positioning a second free end of said at least onestrand to be positioned external of the patient; and maintaining saidfirst end of said at least one strand within the wound for approximately1-3 days for conveying fluid out of the wound and into said strand. 9.The method of claim 8 further comprising the step of applying a separatefluid absorbing material against said second free end of said at leastone strand to convey said fluid absorbed into said at least one strandinto said separate fluid absorbing material.
 10. The method of claim 8wherein said incision or wound is a closed wound or incision and whereinsaid step of inserting a first end of said at least one strand comprisesinserting a first end of said at least one strand inside the wound orincision in between sutures or staples of the closed wound or incision.